BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2191183 · Received July 29, 2011

    Report

    Report Number
    2953200-2011-01366
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ARTERIAL/VESSEL OCCLUSION). RESULTS AND CONCLUSION: (NARROWING IN THE DISTAL AORTA).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 4.5 CM SACCULAR ABDOMINAL AORTIC ANEURYSM APPROX SIX MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 19 MM IN DIAMETER PROXIMALLY AND 21 MM DISTALLY AND IT WAS 2.5 CM IN LENGTH. THERE WAS NARROWING IN THE DISTAL AORTA DUE TO THE SACCULAR SHAPE OF THE ANEURYSM. THE BIFURCATED STENT GRAFT WAS IMPLANTED ON THE RIGHT SIDE. IT WAS REPORTED THAT THE RIGHT LIMB OCCLUDED APPROX THREE MONTHS POST IMPLANTATION PROCEDURE (REF MFR 2953200-2011-01365). THERE WAS NO INTERVENTION AT THAT TIME, AS THERE WAS COLLATERAL FLOW FROM THE LEFT SIDE TO THE RIGHT SIDE. IT WAS REPORTED TWO MONTHS LATER THE PT PRESENTED WITH A COLD LEFT LEG AND UPON EXANIMATION THE LEFT LIMB WAS FOUND TO BE TOTALLY OCCLUDED (REF MFR 2953200-2011-01366). THE PHYSICIAN INSERTED A GUIDEWIRE ON THE LEFT SIDE THEN A BALLOON WAS INFLATED SEVERAL TIMES FOLLOWED BY A THROMBECTOMY WITH FOGARTY CATHETER TO REMOVE THROMBOSIS. AN ANEURX ILIAC LIMB WAS IMPLANTED WITH THE CONTRALATERAL LIMB FROM THE FLOW DIVIDER DOWN TO THE LEFT COMMON FEMORAL ARTERY. ONE WEEK LATER THE PT HAD A FEMORAL TO FEMORAL BYPASS AND THE BLOOD FLOW WAS RESTORED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00556489

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention